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Ganirelix acetate manufacturers

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ganirelix acetate

Injection, pre-filled syringe 0.25 mg/0.5 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Denmark , Finland , Iceland , Norway , Sweden
Comments
Not available: EU, USA, Australia, Canada, MENA, GCC
Manufacturer #6301
A pharmaceutical manufacturer based in the EU that has been active in 50+ countries selling its products in Europe, MENA, LATAM, and NA for 20+ years. Main therapeutic area include oncology and urology. The company's production lines are GMP-compliant. The main dosage forms includes injectable. The company possesses subsidiaries in LATAM

ganirelix acetate

Injection, pre-filled syringe 0,25 mg /0,5ml - 0,5 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Available for
Licensing with supply
Comments
Dossier to be ready Q2 2026
Manufacturer #34073

It is a pharmaceutical company focused on discovering, licensing, and manufacturing generics and added-value medications that meet stringent quality standards set by the FDA and the EMA. They design and produce in accordance with European quality standards. They have over 30 years of experience and have completed over 30 licensing agreements around the world.

ganirelix acetate

Injection 0.5 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA, EU GMP, TGA, Chile, China, New Zealand, Russia, United Kingdom
Registered in
Australia , Chile , China , New Zealand , Russia , United States
Comments
Under Review: VN, CO, MX, SA, SG, BR, MYS, KSA, JO
Manufacturer #29288

This hi-tech enterprise specializes in the research and manufacturing of diverse peptide products. Founded in 1998, it has become one of the leading peptide pharmaceutical companies globally, offering a full range of services including finished dosage products, APIs, and CRO/CMO services. Their finished dosage products are primarily sold domestically, while APIs have international distribution. The company operates a GMP-certified manufacturing facility exceeding 1500 sq. m., regularly inspected by local and international authorities. They focus on several key therapy areas, employing various principal dosage forms, including peptide-based formulations.

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